CA2218369A1 - Transdermal electrotransport delivery of fentanyl and sufentanil - Google Patents

Transdermal electrotransport delivery of fentanyl and sufentanil

Info

Publication number
CA2218369A1
CA2218369A1 CA002218369A CA2218369A CA2218369A1 CA 2218369 A1 CA2218369 A1 CA 2218369A1 CA 002218369 A CA002218369 A CA 002218369A CA 2218369 A CA2218369 A CA 2218369A CA 2218369 A1 CA2218369 A1 CA 2218369A1
Authority
CA
Canada
Prior art keywords
fentanyl
sufentanil
electrotransport
delivery period
over
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002218369A
Other languages
French (fr)
Other versions
CA2218369C (en
Inventor
Mary Southam
Keith Jan Bernstein
Henk Noorduin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alza Corp
Original Assignee
Alza Corporation
Mary Southam
Keith Jan Bernstein
Henk Noorduin
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alza Corporation, Mary Southam, Keith Jan Bernstein, Henk Noorduin filed Critical Alza Corporation
Publication of CA2218369A1 publication Critical patent/CA2218369A1/en
Application granted granted Critical
Publication of CA2218369C publication Critical patent/CA2218369C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Abstract

The invention provides an improved electrotransport drug delivery system for analgesic drugs, namely fentanyl and sufentanil. The fentanyl/sufentanil is provided as a water soluble salt (e.g., fentanyl hydrochloride), preferably in a hydrogel formulation, for use in an electrotransport device (10). In accordance with the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.

Claims (20)

1. A device (10) for transdermally delivering fentanyl by electrotransport, the device including a donor reservoir (26) containing the fentanyl in a form to be delivered by electrotransport, a counter reservoir (28), a source of electrical power (32) electrically connected to the reservoirs (26,28) and a control circuit (19,40) for controlling the applied electrotransport current, the device (10) characterized by:
the donor reservoir (26) being the sole source of fentanyl in the device and containing fentanyl in an amount to provide at least 10 doses of 20µg to 60µg of fentanyl, the control circuit including a patient-controlled switch which activates the device and wherein the reservoirs (26,28), the power source (32) and the controlcircuit (19,40) are designed to deliver by electrotransport about 20µg to about 60µg of fentanyl over a delivery period of up to about 20 minutes and wherein the control circuit is designed to terminate applied electrotransport current after the delivery period.
2. The device of claim 1, wherein the device (10) delivers about 35µg to about 45µg of fentanyl over a delivery period of about 5 to 15 minutes.
3. The device of claim 1, wherein the device (10) delivers about 40µg of fentanyl over the delivery period.
4. The device of claim 1, wherein the device (10) is used to treat less severe pain and the device (10) delivers about 20µg to about 30µg of fentanyl over the delivery period.
5. The device of claim 1, wherein the delivery period is about 10 minutes.
6. The device of claim 1, the device being effective to deliver up to about 100 additional 20µg to 60µg doses of fentanyl by electrotransport over one or more subsequent delivery periods, each delivery period being of up to about 20 minutes duration.
7. The device of claim 1, wherein the donor reservoir (26) comprises a fentanyl salt formulation.
8. The device of claim 7, wherein the fentanyl salt comprises about 1.9 to 2.Owt% of the formulation.
9. The device of claim 8, wherein the fentanyl salt is fentanyl hydrochloride.
10. The device of claim 1, wherein the donor reservoir (26) comprises polyvinyl alcohol.
11. A device (10) for transdermally delivering sufentanil by electrotransport, the device including a donor reservoir (26) containing the sufentanil in a form to be delivered by electrotransport, a counter reservoir (28), a source of electrical power (32) electrically connected to the reservoirs (26,28) and a control circuit (19,40) for controlling the applied electrotransport current, the device (10) characterized by:
the donor reservoir (26) being the sole source of sufentanil in the device and containing sufentanil in an amount to provide at least 10 doses of 2.3µg to 7.0µg of sufentanil, the control circuit including a patient-controlled switch which activates the device and wherein the reservoirs (26,28), the power source (32) and the control circuit (19,40) are designed to deliver by electrotransport about 2.3µg to about 7.0µg of sufentanil over a delivery period of up to about 20 minutes and wherein the control circuit is designed to terminate applied electrotransport current after the delivery period.
12. The device of claim 11, wherein the device (10) delivers about 4µg to about 5.5µg of sufentanil over a delivery period of about 5 to 15 minutes.
13. The device of claim 11, wherein the device (10) delivers about 4.7µg of sufentanil over the delivery period.
14. The device of claim 11, wherein the device (10) is used to treat less severe pain and the device (10) delivers about 2.3µg to about 3.5µg of sufentanil over the delivery period.
15. The device of claim 11, wherein the delivery period is about 10 minutes.
16. The device of claim 11, the device being effective to deliver up to about 100 additional 2.3µg to 7.0µg doses of sufentanil by electrotransport over one or more subsequent delivery periods, each delivery period being of up to about 20 minutes duration.
17. The device of claim 11, wherein the donor reservoir (26) comprises a sufentanil salt formulation.
18. The device of claim 11, wherein the sufentanil salt comprises about 1.9 to 2.0wt% of the formulation.
19. The device of claim 18, wherein the sufentanil salt is sufentanil hydrochloride.
20. The device of claim 11, wherein the donor reservoir (26) comprises polyvinyl alcohol.
CA2218369A 1995-06-05 1996-05-22 Transdermal electrotransport delivery of fentanyl and sufentanil Expired - Fee Related CA2218369C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US46078595A 1995-06-05 1995-06-05
US08/460,785 1995-06-05
PCT/US1996/007380 WO1996039222A1 (en) 1995-06-05 1996-05-22 Device for transdermal electrotransport delivery of fentanyl and sufentanil

Publications (2)

Publication Number Publication Date
CA2218369A1 true CA2218369A1 (en) 1996-12-12
CA2218369C CA2218369C (en) 2010-02-09

Family

ID=23830077

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2218369A Expired - Fee Related CA2218369C (en) 1995-06-05 1996-05-22 Transdermal electrotransport delivery of fentanyl and sufentanil

Country Status (25)

Country Link
US (1) US6171294B1 (en)
EP (1) EP0836511B1 (en)
JP (2) JP2001516227A (en)
KR (1) KR100453140B1 (en)
CN (1) CN1147329C (en)
AT (2) AT409720B (en)
AU (1) AU699774B2 (en)
BE (1) BE1009671A5 (en)
BR (1) BR9609358A (en)
CA (1) CA2218369C (en)
DE (2) DE122006000022I1 (en)
DK (1) DK0836511T3 (en)
ES (1) ES2218586T3 (en)
FI (1) FI974418A (en)
FR (1) FR2734729B1 (en)
GR (1) GR1002983B (en)
IE (1) IE960376A1 (en)
IT (1) IT1285381B1 (en)
LU (1) LU91265I2 (en)
MX (1) MX9709644A (en)
NL (2) NL1003273C2 (en)
NO (1) NO325404B1 (en)
PT (1) PT836511E (en)
WO (1) WO1996039222A1 (en)
ZA (1) ZA964321B (en)

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Also Published As

Publication number Publication date
DE69632131D1 (en) 2004-05-13
NO325404B1 (en) 2008-04-21
AU5924496A (en) 1996-12-24
ES2218586T3 (en) 2004-11-16
FI974418A0 (en) 1997-12-04
JP4339280B2 (en) 2009-10-07
KR19990022349A (en) 1999-03-25
WO1996039222A1 (en) 1996-12-12
LU91265I2 (en) 2006-09-13
IE960376A1 (en) 1996-12-11
GR960100179A (en) 1997-02-28
GR1002983B (en) 1998-10-01
BR9609358A (en) 1999-05-18
US6171294B1 (en) 2001-01-09
PT836511E (en) 2004-08-31
NO975477L (en) 1997-12-05
NL300235I1 (en) 2006-09-01
NO975477D0 (en) 1997-11-28
FR2734729B1 (en) 1999-06-04
NL1003273C2 (en) 1998-10-20
DE122006000022I1 (en) 2006-09-21
ATA903596A (en) 2002-03-15
ITTO960469A0 (en) 1996-05-31
CN1187140A (en) 1998-07-08
FR2734729A1 (en) 1996-12-06
NL1003273A1 (en) 1996-12-06
ITTO960469A1 (en) 1997-12-01
ZA964321B (en) 1997-02-24
AU699774B2 (en) 1998-12-17
CN1147329C (en) 2004-04-28
KR100453140B1 (en) 2005-02-28
BE1009671A5 (en) 1997-06-03
EP0836511B1 (en) 2004-04-07
EP0836511A1 (en) 1998-04-22
IT1285381B1 (en) 1998-06-03
AT409720B (en) 2002-10-25
CA2218369C (en) 2010-02-09
JP2001516227A (en) 2001-09-25
DK0836511T3 (en) 2004-08-09
MX9709644A (en) 1998-07-31
JP2005329246A (en) 2005-12-02
ATE263597T1 (en) 2004-04-15
FI974418A (en) 1997-12-04
DE69632131T2 (en) 2005-04-14

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